UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of occupational sleep health guidance on work engagement of workers aware of difficulty sleeping: non-randomized, single arm and time series trial
Acronym	Effectiveness of occupational sleep health guidance on work engagement
Scientific Title	Effectiveness of occupational sleep health guidance on work engagement of workers aware of difficulty sleeping: non-randomized, single arm and time series trial
Scientific Title:Acronym	Effectiveness of occupational sleep health guidance on work engagement
Region	Japan

Condition
Condition	Healthy industrial population aware of sleep difficulty
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of occupational sleep health guidance for workers aware of sleep difficulty in work engagement
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Work engagement will be measured by the Japanese short version of the Utrecht work engagement scale (Two months after the start of intervention)
Key secondary outcomes	1) Quality of sleep by using Pittsburgh sleep quality index, Japanese Version (Two months after the start of intervention) 2) Work performance by WHO health and work performance questionnaire (short form) Japanese edition (Two months after the start of intervention) 3) Depression by the center for epidemiologic studies depression scale (Two months after the start of intervention) 4) Support resources by analyzing usage status of support resources related to sleep (Two months after the start of intervention)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	We conduct occupational sleep guidance based on cognitive behavioral therapy for insomnia, and we added the two points: assessment of symptom occurrence or exacerbation factors and viewpoint of psychosocial problem solving.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Employees of companies in Japan 2) Those who do not plan to retire within six months 3) Those who are aware of at least one insomnia symptom (difficulty falling asleep, arousal during sleep, early-morning awakening, the lack of a deep sleep feeling ) 4) Those who can participate in the trial for four months including two months non-intervention period and two months intervention period, and twice 30 minutes personal interview (the first time and one month after starting) 5) Those who can consent about the study by documents.
Key exclusion criteria	1) Those who are presumed to be unable to understand and complete the purpose of this study because of their physical and mental disabilities 2) Those who the research staff judges that he/she is inappropriate for participation in this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kana Middle name Last name Kazawa
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
Zip code	734-8553
Address	Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL	+81-82-257-5365
Email	morimich@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Ayako Middle name Last name Toyoshima
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
Zip code	7348553
Address	Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL	+81-82-257-5367
Homepage URL
Email	d161682@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	University Grants
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hiroshima University
Address	Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
Tel	+81822575367
Email	d161682@hiroshima-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	100
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Currently, preparing a result paper.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 02 Day
Date of IRB	2017 Year 08 Month 02 Day
Anticipated trial start date	2017 Year 08 Month 28 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 16 Day
Last modified on	2020 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032766